Medtronic has announced the approval of its Symplicity Spyral renal denervation (RDN) system by the National Medical Products Administration (NMPA) in China.
This marks a milestone as the first RDN system to receive such approval in the country.
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The company is now set to navigate the provincial registration process, although it anticipates initially modest sales in China.
The latest development follows Medtronic’s approval from the US Food and Drug Administration (FDA) for the Symplicity Spyral system in November 2023, along with its launch in India and Canada.
The system also secured clearance under the Greater Bay Area policy in China, allowing commercial sales to hospitals within the region.
It is also known as the Symplicity blood pressure procedure, a minimally invasive technique that utilises radiofrequency energy to target overactive renal nerves linked to hypertension.
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By GlobalDataDuring the procedure, a catheter is inserted into the renal artery, where it delivers energy to the nerves, and is subsequently removed without leaving any implants.
Medtronic senior vice-president and cardiovascular portfolio coronary and renal denervation business president Jason Weidman said: “As the leader in renal denervation, we are looking forward to bringing the Symplicity blood pressure procedure to China, where high blood pressure rates continue to increase.
“As these rates continue to climb, the need for innovative, alternative treatments is strong. The Symplicity procedure can provide people in China with another potential option when seeking high blood pressure solutions, complementing lifestyle modifications and medication.”
The Symplicity Spyral system, tested in more than 25,000 patients worldwide, has demonstrated consistent blood pressure reductions with a mean decrease of 9mmHg at three months, 9.9mmHg at six months, and 18mmHg at three years, alongside very low rates of adverse events.
While it remains investigational in Japan, the system is approved for use commercially in more than 70 countries worldwide.
